The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer

NCT05547529 | Recruiting Phase 3

• 1 other identifier: ENCHENEC
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Survival without local or systemic recurrence

  3(5) years after last patient enrolled

Secondary Outcomes (6)

• Overall survival

  3(5) years after last patient enrolled

• Treatment related complications

  During the procedure

• Number of cycles, frequency of neoadjuvant therapy reduction

  During the procedure

• Correlation between genetic profile and tumor response

  Immediately after the procedure

• Pathological response rate(pCR)

  Immediately after the surgery

Study Arms (2)

Neoadjuvant Chemoradiotherapy

ACTIVE COMPARATOR

Carboplatin (AUC 2 mg/mL per min) and Paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. A total radiation dose of 41,4 Gy was given in 23 fractions of 1,8 Gy, 5 days per week. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.

Procedure: Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.

Neoadjuvant Chemotherapy

EXPERIMENTAL

4 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/ day for 5 days) every 3 weeks. Patients with dysphagia 3 оr with weight loss more then 10% 6 cycles of modified-DCF regimen will be performed (mDCF, docetaxel 50 mg/m2 day, CDDP 50 mg/m2 day and 5-FU at 2400 mg/m2/day for 2 days) every 3 weeks. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.

Procedure: Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Interventions

Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. PROCEDURE

Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.

Neoadjuvant Chemoradiotherapy

Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy PROCEDURE

Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Neoadjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Histologically confirmed squamous cell carcinoma of the esophagus.
• Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition).
• Indications for surgical esophageal resection
• ECOG status 0-1.
• Adequate bone marrow function (White Blood Cells \> 3.0 x 109/L; Neutrophil \> 2.0 × 109/L; Hemoglobin \> 90 g/L; Platelets \> 100 x 109/L).
• Adequate liver function (Total bilirubin \< 1.5 x Upper Level of Normal (ULN); Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 3.0 x ULN);
• Adequate renal function (Glomerular filtration rate (CCr) \> 50 ml/min.
• Adequate cardiac function. Left ventricular ejection fraction \> 50%.
• Age from 18 years to 70

You may not qualify if:

• Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
• Patients with advanced non-operable or metastatic esophageal cancer.
• Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy.
• Patients with another previous or current malignant disease.
• Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin or Fluoruracil.
• Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive.
• Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors, etc.).
• Clinically significant coronary artery disease (NYHA III / IV), congestive heart failure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarction within the last 6 months, or high risk of uncontrolled arrhythmia.
• Chronic inflammatory diseases of the gastrointestinal tract
• Acute infectious diseases.
• Pregnancy or breast feeding.
• Serious concomitant physical and mental illness / abnormalities or territorial reasons that may prevent the patient from participating in the protocol and adherence to the protocol schedule.
• Foreigners or persons with limited legal rights.
• Any medical, geographic, or social circumstance, that in the opinion of the investigator excludes the patient's participation in the protocol.

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Omar Abouhaidar, MD, PhD

CONTACT

+79269125902; abouhaidar@yandex.ru

Parvin Akhmedov

CONTACT

+79267333323; Akhmedovparvin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: September 14, 2022
• Primary Completion: September 14, 2025
• Study Completion (Estimated): September 14, 2027
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)